Moderna Applies to FDA for Full Approval of COVID-19 Vaccine

Kimberly Redmond  |

Image source: Moderna

Moderna Inc (Nasdaq: MRNA) is asking the US Food and Drug Administration (FDA) for full approval of its COVID-19 vaccine for people age 18 and up, the company announced Tuesday.

The Massachusetts-based drugmaker began distributing its experimental double-dose vaccine in December 2020 under an FDA emergency use authorization (EUA), a temporary approval from regulators that requires only two months of clinical data. 

In a press release, Moderna said it initiated the submission of data to the FDA to support a Biologics License Application (BLA) — which requires six months of data — and that it will continue to do so "on a rolling basis over the coming weeks with a request for a Priority Review." 

“We are pleased to announce this important step in the US regulatory process,” said Moderna chief executive officer Stéphane Bancel.

Since December, more than 124 million doses of Moderna’s vaccine have been administered nationwide, according to the US Centers for Disease Control and Prevention (CDC). 

During clinical trials, the vaccine was found to have over 90% efficacy six months after the second dose, Moderna has said.   

Moderna is the second COVID-19 vaccine maker to seek full approval, following Pfizer-BioNTech’s application to the FDA last month. 

The BLA would enable the companies to sell shots directly to consumers.

Additionally, the company said the shot is highly effective in teens ages 12 to 17 and that it plans to seek an EUA this month for adolescents. 

Pfizer’s request to expand its EUA to include adolescents 12 through 15 years old was approved last month. 

Both companies also recently began vaccine trials on the youngest age group yet — 6-month-old to 11-year-old children — with results expected by this coming winter.

As of Tuesday afternoon, more 40% of the US population (135 million) has been fully vaccinated against the coronavirus that causes COVID-19, according to the CDC. Among adults, the rate of fully vaccinated individuals is 51.5%. 

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